A Prospective study on an IMP PET/CT Imaging in Biochemical Recurrence of Prostate Cancer
CASE STUDY TYPE
Interventional clinical trial with radiopharmaceutical product in oncology
BACKGROUND
Prostate cancer (PCa) is now recognised as one of the principal medical problems the male population is facing. Despite radical treatment for clinically localized PCa, early recurrence is relatively common, occurring in up to 50% of patients within 10 years. Correct identification is essential for further treatment planning, as local recurrence may still be treated with local treatment whereas distant metastasis may need systematic treatment.
Thanks to new class of positron emission tomography (PET) radiopharmaceuticals targeting the prostate specific membrane antigen (PSMA), it has become feasible to detect recurrent or metastatic prostate cancer that is otherwise occult on conventional imaging modalities. A new 18F-IMP is a radiolabelled small molecule with high affinity to PSMA with a longer half-life and a better ease of regional distribution compared to 18F-Ga. The goal of the study was to replace the actual standard, 18F-FCH, with 18F-IMP.
METHODS
This was a multicentre, prospective, open label, cross-over comparative study with randomized treatment administration (18F-IMP as an investigational medicinal product or 18F-FCH as a comparator) and with randomized central image evaluation, in patients with a first suspected recurrence of prostate cancer.
OBJECTIVES
PRIMARY OBJECTIVE
- Compare Per-patient detection rate of 18F-IMP PET/CT versus that of 18F-FCH PET/CT
SECONDARY OBJECTIVES
- Comparison of the per-region detection rate
- Comparison of the sensitivity and specificity
- Concordance rate on a region basis
- Comparison of the impact on patient treatment/management
SCIENTIFIC and DATA vALORISATION
- Submission of marketing authorization application for [18F]-IMP to the European Medicines Agency (EMA)
- Client obtained marketing authorisation from EMA
- Support provided during the writing by the client of lead article from the trial results
- Overall excellent client satisfaction
Key factors of success
- ICTA’s expertise in methodology and IT Tools development
- ICTA’s capability to propose innovative solutions for unusual projects
- ICTA’s responsiveness and and capacity to mobilize ICTA’s expertise and skills
LESSONS LEARNED to speed up the start-up phase of the next study
- The importance of close cooperation between ICTA and Sponsor and regular communication, specifically in the early stage of the project and at time of CSR writing in order to define and respond to the sponsor expectations and needs
- ICTA possess a competent staff within various domains of expertise capable of working together in order to quickly and efficiently development of the necessary tool to fulfil the sponsor needs
- Optimal project coordination: Timelines, logistics, sub-contractors management, reporting tools implementation, event management.
CHALLENGES
| KEY CHALLENGES | ICTA’s SOLUTIONS | ICTA’s ACHIEVEMENTS |
|---|---|---|
| Sites selection and patient recruitment Multicenter study carried out in several European countries | ICTA’s longstanding partners in European countries mandated for: . Regulatory submissions . Sites management in 4 European countries: France, Belgium, Spain, The Netherland. | · 40 sites identified · 25 sites selected · 22 active sites ▶ 100% of sites included at least one patient |
| Deadline due to EMA submission · Increase follow-up period | . Close follow-up of site . Close collaboration with the Sponsor who is actively involved with site coordination . Risk management plan . Kick off meeting for CSR writing and close collaboration with the Sponsor to be on time . Additional data analyses/ release to support Sponsor answer to EMA. | . CSR was delivered on due date. . Supportive analyses data provided in due time to support Sponsor response during EMA, marketing authorisation review process. |
| Truth panel management | . Quick development of a new online tool to allow data remote evaluation by expert and eCRF data exchange. | . Mobilization of ClinOps, Data management and IT departments allow to add a new IT tool and more session of the truth panel without changing the study timelines. Data quality ensured |